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Journal of Traditional Chinese Medicine ›› 2024, Vol. 44 ›› Issue (1): 156-162.DOI: 10.19852/j.cnki.jtcm.20231121.004

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Qingchang suppositry (清肠栓) induced remission in patients with mild-to-moderate ulcerative proctitis: a multicenter, prospective, randomized, parallel-controlled clinical trial

DAI Xiaoling1, ZHANG Anming2, LIN Hui3, SHI Bei1, REN Yi2, WEN Hongzhu1, FEI Xiaoyan1, LIN Jiang1()   

  1. 1 Department of Gastroenterology, Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 200032, China
    2 Department of Gastroenterology, Shanghai Putuo Traditional Chinese Medicine hospital, Shanghai 200063, China
    3 Department of Protocology, Shanghai Tianshan Traditional Chinese Medicine hospital, Shanghai 200050, China
  • Received:2022-12-11 Accepted:2023-03-23 Online:2024-02-15 Published:2023-11-21
  • Contact: LIN jiang, Department of Gastroenterology, Longhua hospital affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 200032, China. linjiang@longhua.net. Telephone: +86-64385700-3425
  • Supported by:
    Shanghai Municipal Administration of Traditional Chinese Medicine: Leadship Training Program of Inheritance and Innovation Team of Shanghai School of Traditional Chinese Medicine(2021WXGLP-007)

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Abstract:

OBJECTIVE: To evaluate the efficacy and safety of Qingchang suppository (清肠栓, QCS), a preparation of Chinese herbal medicine, in the induction of remission in patients with mild-to-moderate ulcerative proctitis (UP).

METHODS: We performed a multicenter, prospective, randomized, parallel-controlled trial to evaluate the efficacy of QCS induction therapy in 140 adult patients with mild-to-moderate UP and TCM syndrome of dampness-heat in large intestine. The patients were randomized to receive QCS (study group) or Salicylazosulfapyridine (SASP) suppository (control group) one piece each time, twice a day, per anum for 12 weeks. Mayo score and main symptoms score were evaluated at weeks 0, 2, 4, 8 and 12, rectosigmoidscopy was taken at weeks 0, 4, 8 and 12, Geboes score, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) and safety indexes were assessed at weeks 0 and 12. The primary efficacy endpoint is clinical remission rate, the secondary efficacy endpoints are clinical response rate, mucosa healing rate, Geboes score, the remission rates of the main symptoms, the median day to the remission of the symptom, etc.

RESULTS: There were no statistical difference in the clinical remission rates, the clinical response rates, the mucosa healing rates, Geboes score, ESR and CRP between the two groups. The remission rates of tenesmus and anal burning sensation of the study group were significantly higher than those of the control group (76.5% vs 25.0%, P = 0.009; 74.51% vs 29.63%, P = 0.003). The median day to the remission of purulent bloody stool of the study group was significantly less than that of control group [11 (1, 64) vs 19 (2, 67), P = 0.007]. The patients receiving QCS had a significantly higher mucosa healing rate at week 4 than the patients receiving SASP suppository (71.42% vs 52.85%, P = 0.023). No adverse event occurred in the study group while the adverse events incidence of the control group was 5.7% (P = 0.049).

CONCLUSIONS: QCS could induce the remission of UP as effectively and safely as SASP suppository, and was superior to SASP suppository in relieving the symptoms of tenesmus, anal burning sensation and purulent bloody stool and the time to reach mucosa healing.

Key words: ulcerative proctitis, salicylazosulfapyridine suppository, Qingchang suppositry, randomized controlled trial

Cite this article

DAI Xiaoling, ZHANG Anming, LIN Hui, SHI Bei, REN Yi, WEN Hongzhu, FEI Xiaoyan, LIN Jiang. Qingchang suppositry (清肠栓) induced remission in patients with mild-to-moderate ulcerative proctitis: a multicenter, prospective, randomized, parallel-controlled clinical trial[J]. Journal of Traditional Chinese Medicine, 2024, 44(1): 156-162.